Quality By Design: A Systematic Approach for the Analytical Method Validation

  • Nisha Kumari Abhilashi university, Mandi H.P
  • Bhupendra Singh
  • Geetanjali Saini
  • Amit Chaudhary
  • Kritika Verma
  • Manish Vyas


The scientific way to develop an easy and robust analytical technique for critical analysis is a QbD approach. QbD is a systematic approach to product or method development that begins with predefined objectives and uses science and risk management approaches to achieve product and method understanding and ultimately method control. The aim of the analytical QbD is to achieve quality in measurement. The main objective of this review to explain different steps involved in method development by the QbD approach for analytical method development and describes the implementation of QbD in analytical procedure validation. The advantages of applying QbD principles to analytical technique include discovering and minimizing the source of variability that may lead to poor method robustness and ensuring that the method meets its intended performance need throughout the product and method lifecycle.

Keywords: Quality by design (QbD), Risk Analysis, Analytical method validation


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Kumari N, Singh B, Saini G, Chaudhary A, Verma K, Vyas M. Quality By Design: A Systematic Approach for the Analytical Method Validation. JDDT [Internet]. 15Jun.2019 [cited 2Jul.2020];9(3-s):1006-12. Available from: http://jddtonline.info/index.php/jddt/article/view/3114